Standardized protocols for condom breakage and slippage trials: a proposal.

Abstract

In the absence of well-controlled studies on the clinical effectiveness of condoms against pregnancy and sexually transmitted diseases, breakage and slippage data may provide the best indication of the protection offered by condom use. According to the recent literature, condom breakage rates range from 0% to 12%, with many US studies falling in the 2% to 5% range. Few studies have collected slippage data. In addition to discussing methodological issues associated with these studies, we propose a standardized protocol for future condom breakage and slippage trials and discuss how results may be used to estimate perfect-use and typical-use pregnancy rates.